Dental CariesPhase 4NCT03779698
BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars
A Phase 4 study testing BiodentineTM and Formocresol in people with Dental Caries and Pulpotomy, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in children vital primary molars. A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4- to 8-year-old. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Pulpotomy
- What is being tested?
- BiodentineTM and Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2014to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Patient inclusion criteria:
- Patients with at least two matched bilateral deep carious primary molars indicated for pulpotomy.
- Patients within the age group of four to eight years.
- Healthy patients (both physically and mentally) without any known medical history of systemic conditions contraindicating pulp treatment.
- Cooperative patients who had behavioral ratings "positive" or "definitely positive" according to the Frankl behavior classification scale.
- Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomforts, risks, and benefits.
- No patients were excluded on the basis of gender, race, social or economic background.
Patients not satisfying any of the above-mentioned criteria were excluded from the study.
Teeth inclusion criteria:
Teeth were selected based upon the following clinical and radiographic criteria: Clinically, the study included teeth with restorable crowns, teeth with pathologic carious or mechanical exposure of vital pulps and teeth with no clinical symptoms or evidence of pulp degeneration, such as spontaneous or nocturnal pain, pain on percussion, history of swelling, or sinus tracts and teeth with no tenderness to percussion, physiologic or pathologic mobility. Radiographically, the recruited teeth should have a normal radiographic appearance with healthy supporting tissues, no signs of internal resorption, or pathologic external root resorption and no periapical or inter-radicular pathosis, with at least two-thirds of the root remaining (not more than one-third of the root is physiologically resorbed).
Teeth exclusion criteria:
Teeth were excluded if (1) any of the above-mentioned clinical or radiographic inclusion criteria were not satisfied, (2) hemostasis could not be achieved within 5 minutes by direct contact with a wet cotton pellet, prior to material placement, or (3) the remaining radicular tissue was non-vital (with suppuration or purulence necrosis).
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region, 21589
About this study
Official title: BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars: A 12-Month Randomized Controlled Clinical Trial
The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in children vital primary molars.
A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at 3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests. The level of significance was set at P < 0.05.
Read the detailed description
Methods This study was written according to the Consolidated Standards of Reporting Trials (CONSORT) statement.
Study design A double-blinded, split-mouth, randomized, controlled clinical study was done. Patients This study was carried out on healthy children aged 4- to 8-year-old. The children were selected from the Pediatric Dentistry Clinics, Faculty of Dentistry, King Abdulaziz University (KAU), Jeddah. Each patient had at least 2 matched bilateral carious primary molars requiring pulpotomy. Each parent signed an informed consent for the child's participation in the study. No children were excluded based on gender, race, social or economic status.
Teeth were selected based upon clinical and radiographic criteria. Teeth were unselected if any of the inclusion criteria were not met.
Preoperative periapical radiographs of the molars considered for treatment were taken using the XCP extension cone paralleling technique.
Sample size and power determination Sample size calculation for binary outcome equivalence trials was calculated using sample size calculators of a sealed envelope, randomization and online databases for clinical trials at https://www.sealedenvelope.com/power/binary-equivalence/ Thus, if there is truly no difference between the standard and experimental materials, then 102 teeth (51 for each study material) are required to be 95% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 10%. It is usually prudent to plan to include more than the minimum number of teeth in a study to compensate for loss during follow-up or other causes of attrition. The percentage of teeth that could be lost to follow up at all stages was set at 10% thereby forcing an increase of 5 pairs to the calculated sample size. Thus, the final sample size for this study was calculated to be 112 teeth.
Randomization Since the teeth indicated for pulpotomy must be treated as soon as possible, the patients were included at the time of diagnosis (identification) and randomization for the materials on the sides was done. In order to overcome the variable of the side preferred by the operator, the investigators made sure that both materials equally treated each side. This was performed by carrying out the block randomization technique with closed envelopes. Before recruitment of the patients, 56 sealed envelopes containing the result of randomization were prepared, sealed, and blindly mixed in a box. An envelope was for each block of two contralateral teeth (one pair). After that, the envelopes were numerated blindly from 1 to 56. The envelopes were assigned to the 56 pairs according to the beginning of the treatment (envelop number 1 was assigned to the earliest pair ready for treatment and so on). Each envelope was unsealed after the signature of the informed consent and immediately before the implementation of the first procedure on the right tooth.
One hundred and twelve molars were randomly divided into two treatment groups. Group I comprised 56 molars treated with BiodentineTM (experimental). Group II comprised 56 molars treated with formocresol (control). Each patient received 2 treatments, BiodentineTM on one side of the oral cavity and formocresol on the other side.
Procedures An operator performed the pulpotomy procedures. After application of topical anesthesia (Beutlich LP Pharmaceuticals, USA), local anesthesia was administrated using 27-gauge short needles and syringes loaded with carpules, each one contained 1.8 ml of Lidocaine 2% with epinephrine concentration of 1:100000 (Octocaine® 100, Novocol Healthcare Inc. Cambridge, Ontario, Canada). Complete isolation was performed using a rubber dam and saliva ejector. Removal of caries and deroofing of the pulp chamber were performed using a no. 330 high-speed carbide bur with copious water spray. A sharp sterile spoon excavator or a slow-speed round carbide bur (no. 6 or no. 8) was used for coronal pulp amputation. Then the pulp chamber was washed with normal saline and bleeding was controlled by placing a cotton pellet moistened with water in the pulp chamber for 5 minutes.
In the experimental group (group I), BiodentineTM (Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. In control (group II), a sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. In both groups, all teeth were finally restored using a stainless steel crown (SSC) (3M/ESPE, St. Paul, Minn., USA).
Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months. Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.
Outcome assessment criteria The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Statistical analysis Data were statistically analyzed using the Statistical Package for Social Sciences (SPSS) version 20.0 (SPSS Inc., Chicago, IL). Inter- and intra-examiner agreement was performed using the Kappa statistic. Fisher exact test was used to assess differences in success rates between both groups at 3, 6 or 12 months. McNemar's test was used to compare these rates in each group between pairs of follow up periods. The level of significance was set at P < 0.05.
Ethical Considerations Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, KAU, Jeddah, Kingdom of Saudi Arabia (Approval no. 029-14).
- Conditions
- Dental Caries, Pulpotomy
- Being tested
- BiodentineTM, Formocresol
- Keywords
- BiodentineTM, Formocresol, Primary molars, Pulpotomy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineTMOther
Also called Bioactive dentine substitute
In the experimental group, BiodentineTM was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.
FormocresolDrug
Also called Buckley's Formocresol
In control group, a sterile cotton pellet moistened with 1:5 concentration formocresol then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| BiodentineTM pulpotomy group | Experimental | A Bioactive Dentine Substitute (BiodentineTM, Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Receives: Other: BiodentineTM; Drug: Formocresol |
| Formocresol pulpotomy group | Active comparator | A sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Receives: Other: BiodentineTM; Drug: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Measured: After 3 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Measured: After 6 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Measured: After12 months
Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Measured: After 6 months
Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startMay 2014
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, split-mouth, randomized, controlled clinical study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najlaa Alamoudi, King Abdulaziz University
- Investigators
- Najlaa M Alamoudi, BDS,MSc,DSc, Principal investigator, King Abdulaziz University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779698
- Sponsor's protocol ID
- FacultyofDentistry
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.
PubMed 21703067Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.
PubMed 15344622Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
PubMed 16161395Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
PubMed 22019563Sonmez D, Sari S, Cetinbas T. A Comparison of four pulpotomy techniques in primary molars: a long-term follow-up. J Endod. 2008 Aug;34(8):950-5. doi: 10.1016/j.joen.2008.05.009.
PubMed 18634926Fuks AB, Bimstein E, Guelmann M, Klein H. Assessment of a 2 percent buffered glutaraldehyde solution in pulpotomized primary teeth of schoolchildren. ASDC J Dent Child. 1990 Sep-Oct;57(5):371-5.
PubMed 2120303El Meligy OAES, Alamoudi NM, Allazzam SM, El-Housseiny AAM. BiodentineTM versus formocresol pulpotomy technique in primary molars: a 12-month randomized controlled clinical trial. BMC Oral Health. 2019 Jan 7;19(1):3. doi: 10.1186/s12903-018-0702-4.
PubMed 30612569
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars: A 12-Month Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03779698
- Acronym / sponsor ID
- FacultyofDentistry
- Conditions
- Dental Caries, Pulpotomy
- Keywords
- BiodentineTM, Formocresol, Primary molars, Pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in children vital primary molars.
A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at 3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests. The level of significance was set at P < 0.05.
Detailed description
Methods This study was written according to the Consolidated Standards of Reporting Trials (CONSORT) statement.
Study design A double-blinded, split-mouth, randomized, controlled clinical study was done. Patients This study was carried out on healthy children aged 4- to 8-year-old. The children were selected from the Pediatric Dentistry Clinics, Faculty of Dentistry, King Abdulaziz University (KAU), Jeddah. Each patient had at least 2 matched bilateral carious primary molars requiring pulpotomy. Each parent signed an informed consent for the child's participation in the study. No children were excluded based on gender, race, social or economic status.
Teeth were selected based upon clinical and radiographic criteria. Teeth were unselected if any of the inclusion criteria were not met.
Preoperative periapical radiographs of the molars considered for treatment were taken using the XCP extension cone paralleling technique.
Sample size and power determination Sample size calculation for binary outcome equivalence trials was calculated using sample size calculators of a sealed envelope, randomization and online databases for clinical trials at https://www.sealedenvelope.com/power/binary-equivalence/ Thus, if there is truly no difference between the standard and experimental materials, then 102 teeth (51 for each study material) are required to be 95% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 10%. It is usually prudent to plan to include more than the minimum number of teeth in a study to compensate for loss during follow-up or other causes of attrition. The percentage of teeth that could be lost to follow up at all stages was set at 10% thereby forcing an increase of 5 pairs to the calculated sample size. Thus, the final sample size for this study was calculated to be 112 teeth.
Randomization Since the teeth indicated for pulpotomy must be treated as soon as possible, the patients were included at the time of diagnosis (identification) and randomization for the materials on the sides was done. In order to overcome the variable of the side preferred by the operator, the investigators made sure that both materials equally treated each side. This was performed by carrying out the block randomization technique with closed envelopes. Before recruitment of the patients, 56 sealed envelopes containing the result of randomization were prepared, sealed, and blindly mixed in a box. An envelope was for each block of two contralateral teeth (one pair). After that, the envelopes were numerated blindly from 1 to 56. The envelopes were assigned to the 56 pairs according to the beginning of the treatment (envelop number 1 was assigned to the earliest pair ready for treatment and so on). Each envelope was unsealed after the signature of the informed consent and immediately before the implementation of the first procedure on the right tooth.
One hundred and twelve molars were randomly divided into two treatment groups. Group I comprised 56 molars treated with BiodentineTM (experimental). Group II comprised 56 molars treated with formocresol (control). Each patient received 2 treatments, BiodentineTM on one side of the oral cavity and formocresol on the other side.
Procedures An operator performed the pulpotomy procedures. After application of topical anesthesia (Beutlich LP Pharmaceuticals, USA), local anesthesia was administrated using 27-gauge short needles and syringes loaded with carpules, each one contained 1.8 ml of Lidocaine 2% with epinephrine concentration of 1:100000 (Octocaine® 100, Novocol Healthcare Inc. Cambridge, Ontario, Canada). Complete isolation was performed using a rubber dam and saliva ejector. Removal of caries and deroofing of the pulp chamber were performed using a no. 330 high-speed carbide bur with copious water spray. A sharp sterile spoon excavator or a slow-speed round carbide bur (no. 6 or no. 8) was used for coronal pulp amputation. Then the pulp chamber was washed with normal saline and bleeding was controlled by placing a cotton pellet moistened with water in the pulp chamber for 5 minutes.
In the experimental group (group I), BiodentineTM (Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. In control (group II), a sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. In both groups, all teeth were finally restored using a stainless steel crown (SSC) (3M/ESPE, St. Paul, Minn., USA).
Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months. Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.
Outcome assessment criteria The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Statistical analysis Data were statistically analyzed using the Statistical Package for Social Sciences (SPSS) version 20.0 (SPSS Inc., Chicago, IL). Inter- and intra-examiner agreement was performed using the Kappa statistic. Fisher exact test was used to assess differences in success rates between both groups at 3, 6 or 12 months. McNemar's test was used to compare these rates in each group between pairs of follow up periods. The level of significance was set at P < 0.05.
Ethical Considerations Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, KAU, Jeddah, Kingdom of Saudi Arabia (Approval no. 029-14).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded, split-mouth, randomized, controlled clinical study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group.
| Arm | Type | Receives |
|---|---|---|
| BiodentineTM pulpotomy group | Experimental | Other: BiodentineTM, Drug: FormocresolA Bioactive Dentine Substitute (BiodentineTM, Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. |
| Formocresol pulpotomy group | Active comparator | Other: BiodentineTM, Drug: FormocresolA sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiodentineTMAlso: Bioactive dentine substituteIn the experimental group, BiodentineTM was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months. | Other | BiodentineTM pulpotomy group, Formocresol pulpotomy group |
| FormocresolAlso: Buckley's FormocresolIn control group, a sterile cotton pellet moistened with 1:5 concentration formocresol then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months. | Drug | BiodentineTM pulpotomy group, Formocresol pulpotomy group |
Primary outcome
Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment
Time frame: After 3 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
Time frame: After 6 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
Time frame: After12 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
Time frame: After 6 months
Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
Time frame: After 12 months
Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 21703067Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.
- Background: PubMed 15344622Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.
- Background: PubMed 16161395Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
- Background: PubMed 22019563Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
- Background: PubMed 18634926Sonmez D, Sari S, Cetinbas T. A Comparison of four pulpotomy techniques in primary molars: a long-term follow-up. J Endod. 2008 Aug;34(8):950-5. doi: 10.1016/j.joen.2008.05.009.
- Background: PubMed 2120303Fuks AB, Bimstein E, Guelmann M, Klein H. Assessment of a 2 percent buffered glutaraldehyde solution in pulpotomized primary teeth of schoolchildren. ASDC J Dent Child. 1990 Sep-Oct;57(5):371-5.
- Derived from this study: PubMed 30612569El Meligy OAES, Alamoudi NM, Allazzam SM, El-Housseiny AAM. BiodentineTM versus formocresol pulpotomy technique in primary molars: a 12-month randomized controlled clinical trial. BMC Oral Health. 2019 Jan 7;19(1):3. doi: 10.1186/s12903-018-0702-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najlaa M Alamoudi, BDS,MSc,DSc principal investigator
King Abdulaziz University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BiodentineTM and Formocresol in people with Dental Caries and Pulpotomy, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment (time frame: After 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779698, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.